Risk analysis – FMEA Workshops
FMEA 1 Simple risk assessment process!! Identifying risk Simple method for grading risk Determines appropriate risk reduction options Ultimately assesses risk to patient Applications –Equipment, facilities, products and processes Targets areas of concern
FMEA 2 1.Severity of Impact Negligible, minor, major, critical 2.Occurrence of problem Frequency Highly unlikely, unlikely, likely, high likely 3.Detection of problem Easy, can be detected, difficult to detect, undetectable
FMEA 3 RPN (Risk Priority Number) calculated RPN – numeric value to risk potential 1.Severity 1-4 (1 is negligible) 2.Occurrence 1-4 (1 is highly unlikely) 3.Detection 1-4 (1 is easily detected) RPN = S x O x D (1-48) 1 – lowest risk to patient / highest GMP compliance
FMEA 4 – Risk acceptance RPNDescription Actions required to control process >35Intolerable risk Process re-engineering Additional testing required 20-34Unacceptable risk Must be validated Additional inspections 5-19Tolerable risk Justifications required Evaluate additional tests <5Negligible riskVerification vs validation No additional requirements